Halyard KimVent Endotracheal Tubes Recalled for Cuff Line Detachment
Halyard Health is recalling KimVent Microcuff Endotracheal Tubes because the cuff inflation line may detach from the tube during use.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class I, which is defined as a situation where use of or exposure to a violative product may cause serious adverse health consequences or death. Per the rubric, FDA Class I recalls must be scored at least 4.
Plain-English summary
Halyard Health is recalling KimVent Microcuff Subglottic Suctioning Endotracheal Tubes, 7.5 mm, distributed by Kimberly Clark Global Sales, LLC. The product is used for airway management by oral intubation of the trachea and for the removal of secretions that accumulate in the subglottic space.
The recall is being issued because the cuff inflation line may detach from the endotracheal tube during use. This defect could compromise the device's intended function for airway management and secretion removal.
The recall involves 430 cases, with 10 tubes per case. The affected products were distributed nationwide in the United States and in several international locations, including Australia, Canada, Europe, Hong Kong, New Zealand, and the United Arab Emirates. Specific lot numbers are listed in the structured product information. Healthcare providers and facilities should stop using the affected lots and contact the recalling firm for instructions on return or replacement.
The recalled product
- Product
- KimVent Microcuff Subglottic Suctioning, Endotracheal Tube, 7.5 mm, Distributed by Kimberly Clark Global Sales, LLC. Used for airway management by oral intubation of the trachea and for removal of secretions that accumulate in the subglottic space.
- Manufacturer
- Halyard Health
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Product Code: 13221
- Lot numbers: AA3213
- AA3213V01
- AA3231
- AA3231V01
- AA3249
- AA3249V02
- AA3253
- AA3253V01
- AA3274
- AA3274V03
- AA4062
- AA4062V02
- AA4062V06
- AA4097
- AA4097V01
- AA4097V03
- AA4125V01
- AA4134V02
- AA4140
Distribution
Part of a larger recall action
This product is one of 5 recalled by Halyard Health under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 5 products in this recall →Related recalls
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- HighHalyard Health Recalls KimVent Microcuff Endotracheal Tubes Due to Detachment Risk
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